An existing client requested Medelis to take over a phase III global study. Significant backlog of data existed at the sites, the quality of monitoring was poor, regulatory documentation and Trial Master File were in disarray and patient enrollment had significantly dropped due to upset investigators.
The client was internally preparing for the critical interim analysis to be delayed an additional 6-9 months to allow time for the required clean-up. Not only did Medelis successfully clean up the project, the team was able to deliver the interim analysis according to the original timeline without any additional delays.
Furthermore, Medelis was able to repair the relationships with the sites and double the monthly enrollment rate. Patient enrollment is on track to be completed ahead of schedule.
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